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FDA 510(k) K173388, Exactech Equinoxe Stemless Shoulder, by Exactech, Inc.

FDA 510(k) K173388, Exactech Equinoxe Stemless Shoulder, by Exactech, Inc.

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510(K) Number: K173388
Device Name: Exactech Equinoxe Stemless Shoulder
Manufacturer: Exactech, Inc.
Device Classification Name: Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
Regulation Number: PKC
Classification Product Code: KXA
Date Received: 10/30/2017
Decision Date: 03/09/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic

Total pages: 427
Fully redacted pages: 319
Content pages: 108
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